THERAPEUTIC GOODS ADMINISTRATION - ADVERTISING

 

The OXYMED website was purposed as an educational resource to medical and allied health care professionals (TGA Code (No.2) 2018 30 July 2019). The majority of patients attending OXYMED for Hyperbaric Oxygen Therapy are medical referrals and individual clients exercising their rights and entitlements under self-treatment and self-management. However, in accordance with the TGA (16 July 2020), all medical content and reference has been removed (in excess of 3,500 pages).

  • OXYMED (HTA Monoplace Chambers) are registered under Occupational Health and Safety Act 1985, OHS (Plant) Regulations 1995, Equipment (Public Safety) Act 1994, Equipment (Public Safety) (General) Regulations 1995, Certified Hazard C (Registered) and the Victorian WorkCover Authority Confirmation Number: V9920058.

TGA UPDATE - 16 July 2020

Public Accessed Information versus Health Professionals

https://www.tga.gov.au/directing-advertising-exclusively-health-professionals

Advertising medical conditions are "restricted"

The Australian Therapeutic Goods Administration (TGA) prohibits "providing broad public access to (clinical) documents via an index grouped by medical condition, or allowing searching of such documents by medical conditions". 

Separation is required from the public domain

"Separation is needed from the public domain to ensure advertising (content) is considered to be 'directed exclusively' to health professionals. The material is secured with a username and password, issued by the advertiser (manually or automatically) following confirmation of health professional status through;

  • The provision of a current Australian Health Practitioner Regulation Agency (AHPRA) registration number and associated confirmatory details (such as provider number) for matching against the AHPRA Practitioner information exchange.

  • A declaration that the user is a health professional, in combination with other identity confirmation protections, including an email address with a domain for a hospital, clinic or other business established as providing relevant health services

  • Confirmation of health professional status by visiting sales representatives

  • Other mechanisms to limit the access of the material to specific health professional locations (e.g. material is only accessible from a range of IP addresses used by the hospital concerned or from an application or program configured to run on approved hospital platforms only).

  • Health workers without an AHPRA registration number (e.g. professionals not regulated by AHPRA or procurement officers in hospitals) may present challenges in establishing health professional status, especially if they are operating outside of a hospital or clinic setting. In these cases, a declaration from the worker themselves and/or their employer may be necessary.

  • Information provided via email should only be provided once the professional credentials (e.g. AHPRA or other accreditation) of the individual have been established.

https://www.tga.gov.au/book-page/advertising-regulatory-framework

Limitations on advertising to the public

When advertising therapeutic goods to the public, you cannot advertise:

  • indications for products that are not consistent with those indications that have been accepted in relation to the product's inclusion in the Australian Register of Therapeutic Goods (ARTG) (section 22, 32BJ and 41ML of the Act). Note that this requirement also applies to advertising to health professionals

  • products containing ingredients specified in Schedules 3, 4 or 8 of the current Poisons Standard unless, in the case of Schedule 3 medicines, the ingredients appear in Appendix H of the current Poisons Standard (section 42DL(10) of the Act)

  • biologicals (section 42DL(11) of the Act)

  • autologous human cell and tissue (HCT) products excluded from being subject to therapeutic goods legislation, because one of the criteria for exclusion is not being advertised directly to consumers

  • therapeutic goods that are required to be entered but are not in the ARTG (illegal therapeutic goods) (section 42DL(12) of the Act).

  • You are required to seek permission or approval from TGA before using Restricted representations (representations which refer to serious diseases or conditions) in advertising therapeutic goods to the public.

The Communications Council has a useful list of advertising codes and regulations that apply in Australia.

 

Quality use of medicines

The therapeutic goods advertising legislation is grounded in the Quality Use of Medicines (QUM) framework.

 

Quality Use of Medicines means:

  • Selecting management options wisely by:

    • considering the place of medicines in treating illness and maintaining health, and

    • recognising that there may be better ways than medicine to manage many disorders.

  • Choosing suitable medicines if a medicine is considered necessary so that the best available option is selected by taking into account:

    • the individual

    • the clinical condition

    • risks and benefits

    • dosage and length of treatment

    • any co-existing conditions

    • other therapies

    • monitoring considerations

    • costs for the individual, the community and the health system as a whole.

  • Using medicines safely and effectively to get the best possible results by:

    • monitoring outcomes,

    • minimising misuse, over-use and under-use, and

    • improving people's ability to solve problems related to medication, such as negative effects or managing multiple medications.

 

Under the QUM framework, consumers should be able to select management options wisely; choose suitable medicines (if a medicine is considered necessary); and use medicines safely and effectively. Similar considerations apply to medical devices and other therapeutic goods that may be appropriate for self-selection by consumers for use in the care of themselves or their family.

To support the principles of the QUM framework, industry should be able to provide truthful information to potential consumers about the nature and benefits of therapeutic goods. They should be able to do so through responsible advertising, where this will enhance the health outcomes of the Australian people.

In this context, the Code is pivotal to establishing a robust and effective system for regulating advertising of all therapeutic goods to the public. It aids in giving consumers confidence that the claims they read and hear are well-founded, and it should provide a level playing field for industry.

In the event of any inconsistency between the Act or the Code and other policies, the Act and the Code prevail.

 

World Health Organization criteria

The advertising legislation, especially the Code, also draws on concepts used in the World Health Organisation: Ethical Criteria for Medicinal Drug Promotion 1988, namely:

  1. Promotion refers to all informational activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal products.

  2. All promotion-making claims concerning medicinal drugs should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste. They should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug use or give rise to undue risks.

  3. Comparison of products should be factual, fair and capable of substantiation.

  4. Advertisements to the general public should help people to make rational decisions on the use of drugs determined to be legally available without prescription. While they should take into account people's legitimate desire for information regarding their health, they should not take undue advantage of people's concern for their health, nor mislead the consumer into unwisely relying on medicines to solve physical, emotional or mood problems.

  5. The provision of free samples to the general public for promotional purposes is difficult to justify from a health perspective.

  6. Advertisements may claim that a drug can cure, prevent or relieve an ailment only if this can be substantiated.

  7. Language which brings fear or distress should not be used.

  8. Advertisements should not be allowed for certain serious conditions that can be treated only by qualified health practitioners.

S28 Restricted representations

  1. For the purposes of section 42DD of the Act, a form of a disease, condition, ailment or defect is a serious form if: (a) it is medically accepted that the form requires diagnosis or treatment or supervision by a suitably qualified health professional; except where the form has been medically diagnosed and medically accepted as being suitable for self-treatment and management.

S15 Scientific or clinical representations

Where an advertisement makes a scientific or clinical representation: 

  1. any scientific or clinical terminology must be appropriate, clearly communicated and able to be readily understood by the audience to whom it is directed; and 

  2. any scientific or clinical representation must be consistent with the body of scientific or clinical evidence applicable to the advertised therapeutic goods.

  3. Where an advertisement contains a citation to scientific or clinical literature, either explicitly or impliedly: 

  4. any research results must identify the researcher and financial sponsor of the research, where the advertiser knows, or ought reasonably to have known, that information; and 

  5. the study must be sufficiently identified to enable consumers to access it.

S23 Complementary medicines

If an advertisement for a complementary medicine includes a claim or group of claims based on evidence of a history of traditional use, the reliance on this traditional use and paradigm must be disclosed in the advertisement and the disclosure must be prominently displayed or communicated in the advertisement.

 

S29 Restricted representations—public interest criteria

For the purposes of paragraph 42DF(4)(c) of the Act, the public interest criteria are as follows:

  1. whether the reference would be likely to take advantage of the vulnerability of consumers, or particular groups of consumers, when faced with the disease, condition, ailment or defect;

  2. whether the reference would be likely to result in consumers not seeking timely professional medical advice where required (such as where that advice is important to prevent negative health consequences, morbidity or mortality, or deterioration or progression of the disease, condition, ailment or defect);

  3. whether the reference would be likely (alone, through repetition or together with other references) to have a negative impact on public health (or to have an effect on persons other than those to whom the advertisement is directed);

  4. such other aspects of the public interest as may appear to be appropriate to the Secretary.

 

S30 Prohibited representations

For the purposes of paragraph 6B(1)(b) of the Regulations, the following representations are prohibited representations:

  1. any representation regarding abortifacient action;

  2. any representation regarding the treatment, cure, prevention, diagnosis (including screening), monitoring or susceptibility of, or predisposition to, the following diseases: (i) neoplastic disease; (ii) sexually transmitted diseases; (iii) human immunodeficiency virus and acquired immune deficiency syndrome (HIV AIDS); (iv) hepatitis C virus (HCV); (v) mental illness.

OXYMED Australia

643 Chapel Street South Yarra 3141 Australia

T: +61 3 9826 9898  E: info@oxymed.com.au